法规动态

FDA、EMA、TGA 及全球法规动态

#Octreotide ×

2026年9月15日•1 分钟阅读

FDA Approves Sun Pharm ANDA077373 for Octreotide Acetate Injectable Products

FDA granted approval for Sun Pharm's ANDA077373 covering two discontinued octreotide acetate injectable products, with labeling updates approved in 2013 and 2017.

2026年9月3日•1 分钟阅读

FDA Approves Fresenius Kabi’s OCTREOTIDE Acetate Injectable (ANDA 077457)

The FDA has granted approval for Fresenius Kabi USA’s preservative‑free OCTREOTIDE acetate injectable products under ANDA 077457, covering three dosage strengths for injection.

2026年8月30日•1 分钟阅读

FDA Approves ANDA076330 for Octreotide Acetate Injection

The FDA has approved application ANDA076330 for octreotide acetate injectable products manufactured by Hikma Pharmaceuticals, available in two dosage strengths.